Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT00064181
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFIRI regimen — DRUG
  • capecitabine — DRUG
  • celecoxib — DRUG
  • fluorouracil — DRUG
  • irinotecan hydrochloride — DRUG
  • leucovorin calcium — DRUG

Study Details

RATIONALE: Drugs used in chemotherapy such as irinotecan, capecitabine, leucovorin, and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor. It is not yet known which combination chemotherapy regimen with or without celecoxib is more effective in treating metastatic colorectal cancer. PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens and celecoxib to see how well they work compared to two combination chemotherapy regimens alone in treating patients with metastatic colorectal cancer.

Key Dates

Start date
May 31, 2003
Status verified
Sep 2012
Primary completion
Jan 31, 2005

Study Design

Enrollment
86 participants (actual)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

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